Regulatory Affairs

11
Jan

FTC Issues Newly Revised Health Product Compliance Guidance – How About That!

Just one day after expressing my opinion that more needs to be done to enhance dietary supplement regulations and requirements, I found that the FTC recently revised an older guidance (from 1998) entitled Dietary Supplements: An Advertising Guide for Industry. The new guidance entitled Health Product Compliance Guidance (here), was issued on December 20, 2022 […]

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10
Jan

Failure of Congress to Take Action on Dietary Supplements Keeps Status Quo

Seemingly every day, there is news of a dietary supplement (DS) running afoul of regulations, either by containing a hidden drug ingredient or claiming the product is used in the cure, mitigation, or treatment of a disease, running afoul of the existing FDA dietary supplement regulations.  Congress had the opportunity to redefine FDA oversight of […]

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09
Jan

Drug Shortages Continue to Plague the Industry

Whether it be the supply chain, compliance issues, manufacturing issues, issues with packaging components, or just plain bad luck, the number of drug shortages continues to plague the pharmaceutical industry both domestically and overseas.  The FDA current shortage list (here) contains 191 entries and, of that number, only 66 have been resolved, leaving 125 drug […]

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23
Dec

Analytical Method Validation, Verification, or Qualification – What to use and when?

Analytical development and/or QC groups at early-stage pharmaceuticals and biopharmaceuticals often ask themselves about the level of level of confirmation of suitability required for their methods. Often the term ‘validation’ is used without understanding the full implications of the term. Sometimes, the terms validation, qualification and verification are used interchangeably. While ‘validation’ is well understood […]

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21
Dec

Revised Guidance on Controlled Correspondence for ANDAs

The FDA published a revised guidance issue today (here) that revises a December 2020 guidance on Controlled Correspondence (CC) by the Office of Generic Drugs.  This December 2020 guidance is being updated to reflect the new provisions of GDUFA III and its commitment letter relative to the submission of CC. “This guidance provides information regarding the […]

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20
Dec

December May Not Be a Month to Remember for OGD Approvals

Taking a look at the unofficial approval information on the FDA website through December 16th, we found only twenty‑five ANDAs receiving full‑approval actions and six receiving tentative‑approval actions.  That is a total of (obviously) thirty‑one approval actions.  Given that number, if the OGD could double its approval output by the end of the month, that would […]

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16
Dec

New Reporting Structure and Metrics for OGD Statistical Reports

Well, the new statistics started rolling off the assembly line last night and appear in a new report that combines the generics monthly statistical report and the Quarterly Report.  The new name of the report, which we discussed in a blog post (here), is the Generic Drugs Program Monthly and Quarterly Activities Report.  We will […]

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15
Dec

Devices to Head onto the Inspection Delay or Refusal Bandwagon

Since July 9, 2012, the day that the Food and Drug Administration Safety and Innovation Act (FDASIA) (Public 19 Law 112-144) was signed into law, drug products are deemed “adulterated for which a manufacturer processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or […]

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